Protection From Cisplatin Ototoxicity by Lactated Ringers

University of Oklahoma (OU)

Status and phase: Withdrawn; Phase 1

Conditions: Hearing Loss

Treatments: Drug: Normal Saline and 0.3% ofloxacin; Drug: Lactated Ringer's with 0.03% Ofloxacin

Study type: Interventional

Funder types: Other

Identifiers

NCT00584155

Lactated Ringers - Berryhill

Details and patient eligibility

About

The purpose of this study is to determine if Lactated Ringer's solution is effective in patients undergoing chemotherapy with cisplatin for head and neck cancer in regards to cisplatin-induced hearing loss.

Full description

About one-third of people who have been given Cisplatin, as part of their chemotherapy treatment, develop hearing loss. The purpose of this study is to determine if some degree of hearing loss can be prevented by use of Lactated Ringer's solution in the middle ear. To study this, patients will use drops in their ears; Lactated Ringer's will be placed in one ear and an inactive saline solution will be placed in the other. Ofloxacin, an eardrop antibiotic will be placed in each ear at the same time. Each participant will receive a hearing evaluation before each dose of Cisplatin and another evaluation 2 to 4 weeks after the final treatment.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with cancer to be treated with cisplatin.
• Patients expected to receive a minimum of 3 rounds of chemotherapy.
• Patients receiving a minimum dose of cisplatin of 70 mg/m2

Exclusion criteria

• Patients who have had middle ear surgery.
• Patients who have active external or middle ear disease
• Patients who have preceding pure tone average of >40 dB HL

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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0 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Each patient will receive a bottle containing normal saline and 0.03% ofloxacin.

Treatment:

Drug: Normal Saline and 0.3% ofloxacin

2

Experimental group

Description:

Each patient will receive a bottle containing Lactated Ringer's solution and 0.03% ofloxacin.

Treatment:

Drug: Lactated Ringer's with 0.03% Ofloxacin